BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACS MULTI-LINK CORONARY STENT SYSTEM

    MDR report key: 3040961 · Received April 8, 2013

    Report

    Report Number
    2024168-2013-02074
    Event Type
    Death
    Date Received
    April 8, 2013
    Date of Event
    August 22, 2012
    Report Date
    March 14, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED BASED ON DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATED BASED ON DATE OF PUBLICATION. STENT: 25 CORDIS ENTERPRISE, 7 WINGSPAN, 7 NEUROFORM, 5 WALLSTENT, 2 ZILVER. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED, DEATH IS LISTED IN INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. IT WAS REPORTED THE MULTI-LINK STENT WAS USED IN A PATIENT WITH ACUTE ISCHEMIC STROKE DUE TO MIDDLE CEREBRAL ARTERY OCCLUSION. ALTHOUGH THE SPECIFIC PRODUCT IS UNKNOWN, IT SHOULD BE NOTED THAT THE VISION IFU STATES THAT THE MULTI-LINK VISION RX AND MULTI-LINK VISION OTW CORONARY STENT SYSTEMS ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH LESS THAN OR EQUAL TO 25 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 2.75 MM TO 4.0 MM.

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE REVIEW ENTITLED: A CONTROLLED TRIAL OF REVASCULARIZATION IN ACUTE STROKE. THE PURPOSE OF THE STUDY WAS TO COMPARE SAFETY AND UTILITY OF INTRAARTERIAL REVASCULARIZATION WITH USE OF STENTS TO NO REVASCULARIZATION IN PATIENTS WHO EITHER FAILED TO RESPOND TO INTRAVENOUS THROMBOLYSIS (IVT) OR HAVE CONTRAINDICATIONS TO IVT. ONE HUNDRED THIRTY-ONE PATIENTS WITH ACUTE ISCHEMIC STROKE DUE TO MIDDLE CEREBRAL ARTERY OCCLUSION WERE ENROLLED. MULTIPLE NON-ABBOTT STENTS AND BALLOONS WERE USED OFF-LABEL IN THIS STUDY INCLUDING TWO ACCULINK STENTS AND ONE MULTILINK STENT. CLINICAL RESULTS INDICATE THAT 7-DAY MORTALITY WAS 8, AND 3-MONTH MORTALITY WAS 15. THE ARTICLE DID NOT INDICATE THE PARTICULAR BRAND OF STENT THAT WAS IMPLANTED IN THESE PATIENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144044 ACS MULTI-LINK CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death CONCOMITANT MEDICAL DEVICES